Investigating how overnutrition affects fat tissue and insulin resistance
Short-term High-fat Overnutrition Induces Insulin Resistance in White Adipose Tissue
NA · German Diabetes Center · NCT06193668
This study is testing how a short-term high-fat diet affects fat tissue and insulin resistance in people to see if it leads to problems like type 2 diabetes.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | German Diabetes Center (other) |
| Locations | 1 site (Düsseldorf, North Rhine-Westphalia) |
| Trial ID | NCT06193668 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the mechanisms behind insulin resistance in white adipose tissue (WAT) induced by short-term high-fat diet overnutrition. Participants will be randomly assigned to either a hypercaloric high-fat diet or a macronutrient-balanced diet for three weeks. The study will analyze differences in fatty acid and glucose metabolism between the two groups to better understand the impact of diet on insulin sensitivity. The findings could provide insights into the metabolic disturbances associated with type 2 diabetes.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 40 with a BMI under 29 who do not engage in regular sports activities.
Not a fit: Patients with diabetes, chronic diseases, or those on medications affecting metabolism are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dietary recommendations for preventing or managing insulin resistance and type 2 diabetes.
How similar studies have performed: Previous studies have shown promising results in understanding dietary impacts on insulin resistance, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 40 years * BMI \< 29 kg/m2 * Sport inactive (\<1x /week) * Capacity to consent Exclusion Criteria: * Diabetes mellitus disease * Acute coronary heart syndrome (myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack in the last 3 months before study participation) * Acute infectious disease * Taking blood glucose-lowering drugs * Diseases or drugs affecting the immune system and allergies to drugs used in the study * Drugs with potential metabolic effects * Chronic liver disease (hepatitis, gallbladder disease, elevated liver enzymes (ALT \> 300 U/L)) * Chronic inflammatory bowel diseases * Rheumatic diseases * Hyper- or hypothyroidism of the thyroid gland * Renal insufficiency, administration of iodine-containing contrast media in the last 2 days * Chronic lung diseases * cancerous diseases * Addictive diseases, psychiatric diseases * Pregnancy, breastfeeding * Shift workers * Anemia (Hb \<12 g/dl) * Disorders of hemostasis * Regular use of antithrombotic drugs * Alcohol consumption, smoking * Conditions that do not permit an MRI examination
Where this trial is running
Düsseldorf, North Rhine-Westphalia
- Georgia Xourafa — Düsseldorf, North Rhine-Westphalia, Germany (RECRUITING)
Study contacts
- Study coordinator: Theresia Sarabhai, MD
- Email: theresia.sarabhai@ddz.de
- Phone: 0173-9473478
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lipid-induced Insulin Resistance